Cross-DisciplinaryWorking Groups

Assessment of in vivo Human Metabolism Working Group

Objectives: Conduct a survey of current industry practices in the assessment of in vivo human drug metabolism.

Background: The Working Group was chartered in 1H2012. Human radiochemical excretion and metabolism studies are a standard aspect of most small molecule drug development programs. The 2008 Safety Testing of Drug Metabolites, ICH M3(R2), M3(R2) Q&A, ICH S9 regulatory guidances (hereafter referred to as “MIST guidances” (metabolites in safety testing guidances)), and new technologies such as accelerator mass spectrometry (AMS) and high resolution LCMS/ MS may be changing industry perceptions of how, when and why these studies are run. Likewise, new study designs, made possible by these technologies, and sometimes involving the administration of much lower doses of radioactivity, or no radioactive tracer at all, have resulted in divergent industry approaches to the in vivo assessment of human drug metabolism.

One consensus electronic survey per member company will be completed electronically. Company affiliations will be removed by the IQ Consortium and will not be connected to the results.

Survey Overview:
1. Metrics How many and what types of human metabolism studies have been run over the last 5 years.
2. Study Timing – When do you currently undertake preclinical and clinical metabolism studies
3. Outsourcing
4. Impact of MIST guidances
5. Clinical study design
6. Bioanalytical aspects
7. MIST Guidances Strategy
8. Usefulness of survey results